Efficacy of SynEx™ Wound Rinse in Civilian Surrogates of Combat Injury Wounds
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Wound healing environment composite score
研究概览
简要总结
The purpose of this interventional study is to compare SynEx Wound Cleanser with the current routine care (Saline) in traumatic wounds. Participants with gunshot, penetrating or burn wounds who participate will be asked to attend up to four study visits, use the assigned wound cleanser and complete brief surveys about their healing and well-being related to the wound healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute penetrating, puncture and burn wounds of the upper or lower extremity that meet the inclusion and
排除标准
- •for the wound type:
- •Penetrating, puncture or laceration wounds: stage II-III (partial to full thickness loss of dermis) excluding diabetic or venous wounds, and pressure ulcers and perforated wounds (except gunshot wounds) and wounds with exposed bones, facia or muscle.
- •Gunshot wounds (GSW): Grade I - II on the Red Cross Classification of War Wounds6 (diameter of entry + exit wounds < 10 cm, wound cavity or not, no fracture or fraction without clinically significant comminution). Non-penetrating, penetrating, or perforated GSW are included. GSW with suspected vascular injuries or nerve damage are excluded.
- •Burns: partial thickness injury ≤ 9% TBSA. Thermal burn from flame or scald, chemical burns, and electrical burn are included. Radiation and frostbite burns are excluded.
- •Males and females ≥18 years old.
- •Has access to a computer or mobile device for telepresence visits.
- •Able to give informed consent and willing to comply with all required study procedures.
- •Exclusion Criteria:
- •Any wound likely to require irrigation and debridement in an operating room (OR) setting.
- •Concomitant processes sustained contemporaneously with the dermal injury (e.g., inhalational injury requiring ventilation, electrical injury with cardiac damage or arrhythmia, sepsis, traumatic brain injury, other serious or unstabilized organ damage from trauma, etc.).
- •> 72 hrs from initial injury.
- •Pregnant or lactating females.
- •Patients with known allergy(ies) to any of the components of the study irrigation system.
- •Patients who are considered by the investigator for any reason to be an unsuitable candidate.
研究组 & 干预措施
SynEx
The experimental arm will receive SynEx Wound Cleanser to cleanse the wound as directed by their healthcare provider.
干预措施: SynEx Wound Cleanser (Device)
Saline
The comparator arm will receive Saline Solution to cleanse the wound as directed by their healthcare provider.
干预措施: Saline (Other)
结局指标
主要结局
Wound healing environment composite score
时间窗: 14 days
The composite score is a summation of wound characteristics such size, depth, edges and undermining. Scores range from range of 13 to 60, representing wound regeneration to degeneration respectively).
次要结局
未报告次要终点